Long-term Complications of Unintentional Dural Puncture During Labour Epidurals and Epidural Blood Patch.

NCT04696627 | Completed

• 1 other identifier: 20-03
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to evaluate long-term consequences of unintentional dural puncture in women who had this complication during labor epidural insertion at Mount Sinai Hospital. A dural puncture is the perforation of the dura mater (one of the layers protecting the brain and the spinal cord) by the needle that is used to find and place a catheter in the epidural space. A puncture will cause a leakage of cerebrospinal fluid through the dura that results in an acute and usually self-limited headache in half of patients who have this complication. The usual treatment for this complication is conservative with the use of oral medications like acetaminophen, anti-inflammatory and narcotics. In the severely symptomatic patient, the injection of blood in the epidural space is a more invasive approach performed to "patch" the hole that was created in the dura (epidural blood patch). The objective is to determine whether or not there is a risk of developing long-term effects from the unintentional dural puncture and its treatment by epidural blood patch by comparing women who had a dural puncture during their labour epidural insertion with or without an epidural blood patch with women who received an epidural but did not have a dural puncture during the same period of time. The hypothesis is that women who had unintentional dural punctures during epidural insertion will develop long-term effects such as chronic headache, chronic backache, chronic auditory or visual disturbances and chronic disability more frequently than women who received an epidural but did not sustain a dural puncture. The investigators also hypothesize that the use of epidural blood patch may change the course of these complications.

Conditions

Post-Dural Puncture Headache; Chronic Headache

Keywords

post-dural puncture headache; labour epidural; chronic headache; chronic backache

Outcome Measures

Primary Outcomes (1)

• Presence of Chronic headache - questionnaire

  The presence of chronic headache defined as pain that lasts or recurs for more than three months.

  3 months

Secondary Outcomes (5)

• Presence of Chronic lower back pain - questionnaire

  3 months

• Presence of Chronic auditory impairment - questionnaire

  3 months

• Presence of Chronic visual impairment - questionnaire

  3 months

• Medical interventions for pain/impairment - questionnaire

  3 months

• Pain disability index - questionnaire

  3 months

Study Arms (3)

Dural puncture

Patients with well-documented recognized unintentional dural punctures during their labor epidural insertion at Mount Sinai Hospital from January 2015 to December 2019.

Other: Questionnaire

Dural puncture with blood patch

Patients with well-documented recognized unintentional dural punctures during their labor epidural insertion at Mount Sinai Hospital from January 2015 to December 2019 that were treated with an epidural blood patch.

Other: Questionnaire

No dural puncture

Patients who did not have recognized unintentional dural punctures during their labor epidural insertion at Mount Sinai Hospital from January 2015 to December 2019.

Other: Questionnaire

Interventions

Questionnaire OTHER

Participants from all 3 groups will be interviewed

Dural puncture; Dural puncture with blood patch; No dural puncture

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with labour epidurals inserted at Mount Sinai hospital from January 2015 to December 2019 with well-documented recognized unintentional dural punctures will be invited to participate. Control patients who received labor epidural matched by month of delivery, age, and body mass index (grouped as either below or above a body mass index of 40) will also be approached for enrollment.

You may qualify if:

• All patients with well-documented recognized unintentional dural punctures during their labor epidural insertion at Mount Sinai Hospital from January 2015 to December 2019 will be approached for enrollment. Control patients who received labor epidural matched by month of delivery and age will also be approached for enrollment.

You may not qualify if:

• Patients with preexisting symptoms of chronic headache, or any of the secondary outcomes prior to the unintentional dural puncture will be excluded from this study.

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Post-Dural Puncture Headache; Headache Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jose Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: February 12, 2021
• Primary Completion: May 10, 2021
• Study Completion: May 11, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-02

Locations

CA (1)